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Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation

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ClinicalTrials.gov Identifier: NCT03502122
Recruitment Status : Completed
First Posted : April 18, 2018
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Chun-Chuan Chen, National Central University, Taiwan

Brief Summary:
This study aims to design and verify a multi-mode smart assistive device system for Stroke Rehabilitation by using EEG, fMRI, IMU and questioners

Condition or disease Intervention/treatment Phase
Stroke Other: VR rehabilitation for motor function Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation
Actual Study Start Date : April 24, 2012
Actual Primary Completion Date : May 28, 2014
Actual Study Completion Date : May 28, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VR rehabilitation
Virtual Reality based rehabilitation therapy for motor function, 1 hour a time at an intensity of three times per week over 8 weeks (total, 24 sessions).
Other: VR rehabilitation for motor function
rehabilitation for motor function
Other Name: VR rehabilitation therapy

Active Comparator: control- conventional rehabilitation
conventional rehabilitation therapy for motor function, 1 hour a time at an intensity of three times per week over 8 weeks (total, 24 sessions).
Other: VR rehabilitation for motor function
rehabilitation for motor function
Other Name: VR rehabilitation therapy




Primary Outcome Measures :
  1. Change in FUGL- MEYER ASSESSMENT OF PHYSICAL PERFORMANCE (FMA) [ Time Frame: pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention ) ]
    FUGL- MEYER ASSESSMENT OF PHYSICAL PERFORMANCE (FMA)


Secondary Outcome Measures :
  1. change in upper extremity performance evaluation test for the elderly (TEMPA) [ Time Frame: pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention ) ]
    upper extremity performance evaluation test for the elderly (TEMPA)

  2. change in Brunnstrom stage [ Time Frame: pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention ) ]
    Brunnstrom stage

  3. change in Wolf motor function [ Time Frame: pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention ) ]
    Wolf motor function



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • the first time hemiparetic stroke;
  • diagnosis confirmed by a physician on the basis of the findings of neurological examinations and brain imaging (magnetic resonance imaging or computed tomography scan);
  • aged between 20 and 85 years;
  • Brunnstrom's stage II to V over the proximal and distal part of the upper extremity on the affected side;
  • no cognitive dysfunction, measured by the Mini-Mental State Exam (≧24; suggested by 36 with respect to age and educational level)
  • willing/able to participate and having signed an informed consent form.

Exclusion Criteria:

  • unstable vital sign
  • irreversible contracture over any of the joints of the affected upper extremity
  • history of surgery, fracture, arthritis, pain, or any other complications that might influence the recovery of upper extremity function like aphasia, apraxia and neglect;
  • having spasticity, as measured using the Modified Ashworth scale (score > 2);
  • poststroke seizure;
  • heart attack within 3 months poststroke; cortical lesions in any of the five core motor areas of interest, including the bilateral M1, the bilateral PM, and the SMA.

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Responsible Party: Chun-Chuan Chen, Associate professor, National Central University, Taiwan
ClinicalTrials.gov Identifier: NCT03502122     History of Changes
Other Study ID Numbers: 201012009IA
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided .

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chun-Chuan Chen, National Central University, Taiwan:
stroke
rehabilitation

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases